Page 117 - Assurance of Sterility for Sensitive Combination Products and Materials

Package/container closures 101

Tyvek ®

Tyvek ® Tyvek ®

Alignment
Plate

®
Free tail 90° Tyvek bent Film bent Tray
(180°) (180°)
(A) (B) (C) (D) (E)

Fig. 5.6 Seal strength measurement techniques.

Table 5.6 Seal strength measurement techniques details.
Technique Tail holding
A Unsupported (“Free Tail”, angle can vary throughout the test)
B Supported 90° (Fixed Angle by hand or better using a support)
C Top Web Bent (supported 180°)
D Film/Bottom Web (supported 180°)
E Free Tail Lid Material Upper Bent 180°

The strategic development of validation protocols enables industry to
assure safety to the patient while implementing efficient and cost- effective
packaging systems. A model example of this is when Dupont made a global
change in Tyvek raw material. Tyvek has been used extensively for packag-
ing undergoing gaseous-based sterilization modalities because of its unique
permeability and long successful history. DuPont provided a path that en-
abled their customers to transition smoothly from the older legacy Tyvek
to a new product by working closely with global regulatory bodies as well
as their customers. This enabled the Tyvek transition without individual
medical device companies revalidating all their products which would have
resulted in product disruptions to the patients and higher cost without im-
proving safety of the products.
In 2015, DuPont published the results of the equivalence testing proto-
®
col comparing “transition” Tyvek produced on the newer manufacturing
®
lines and “legacy” Tyvek produced on the older manufacturing lines. This
included over 50,000 seal strength measurements, 78 different packaging
applications marketed by 55 medical device manufacturers throughout the